Citizen Petition to the US Food and Drug Administration to Change Prescribing Guidelines: The Metformin Experience

Lipska, Kasia J.; Flory, James; Hennessy, Sean; Inzucchi, Silvio E.

doi:10.1161/circulationaha.116.023041

Cited by 29 publications

(28 citation statements)

References 4 publications

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“…8,29,30 In 2016, the US Food and Drug Administration adopted less restrictive guidelines on the use of metformin in chronic kidney disease. 31 Future studies should examine the impact of this change. We also found that DPP-4 inhibitor use was similar by age, whereas GLP-1 receptor agonists were used less commonly in older adult visits.…”

Section: Discussionmentioning

confidence: 99%

Differences in National Diabetes Treatment Patterns and Trends between Older and Younger Adults

Pilla

Segal

Alexander

et al. 2019

J American Geriatrics Society

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BACKGROUND/OBJECTIVES: The treatment of type 2 diabetes in older adults requires special considerations including avoidance of hypoglycemia, yet variation in diabetes treatment with aging is not well understood. In this study, we compared nationally representative diabetes treatment patterns and trends between older adults (≥65 y) and younger adults (30–64 y). DESIGN: Repeated cross-sectional physician surveys from 2006 to 2015. SETTING: The National Ambulatory Medical Care Survey, an annual probability sample of visits to office-based US physicians. PARTICIPANTS: Adults with type 2 diabetes using one or more diabetes medications. MEASUREMENTS: Proportions of visits in which patients treated with each diabetes medication class were compared between older and younger adults in 2-year intervals. RESULTS: From 2006 to 2015, the average number of yearly visits for older and younger adults was 25.4 million and 24.2 million, respectively. In 2014–2015, visits for older compared with younger adults involved less use of metformin (56.0% vs 70.0%; p < .001) and glucagon-like peptide 1 receptor agonists (2.9% vs 6.2%; p = .004), and more use of long-acting insulin (30.2% vs 22.4%; p = .017); other classes were used similarly. During the study period, long-acting insulin use increased markedly in older adults, particularly between 2010 and 2015 where it rose from 12.5% to 30.2% of visits (P-trend <.001). In younger adult visits, long-acting insulin use increased modestly (17.2% to 22.4%) and at a slower rate compared with older adult visits (p < .001). CONCLUSION: The ambulatory treatment of type 2 diabetes differs between older and younger adults, with the treatment of older adults characterized by low use of newer diabetes medications and a greater and rapidly increasing use of long-acting insulin. These findings call for further research clarifying the comparative effectiveness and safety of newer diabetes medications and long-acting insulin to optimize diabetes care for older patients.

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Section: Discussionmentioning

confidence: 99%

Differences in National Diabetes Treatment Patterns and Trends between Older and Younger Adults

Pilla

Segal

Alexander

et al. 2019

J American Geriatrics Society

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“…Based on these data and two citizen petitions, in April 2016, the FDA changed the labelling of all metformincontaining medications in the USA for use in individuals with mild and moderate impairment in kidney function [39]. The changes allowed for more widespread use of the drug, more akin to standards in place in the UK.…”

Section: Non-glycaemic Effectsmentioning

confidence: 99%

Metformin: clinical use in type 2 diabetes

2017

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“…Metformin is safe and tolerable with the exception of the risk of lactic acidosis in patients with risk factors for lactic acidosis [59], including impairment of renal, cardiac, and hepatic function [60][61][62]. Another concern is metformin-induced vitamin B12 deficiency; patients who receive long-term metformin treatment (>6 months) at large doses have developed B12 deficiency [63,64], so that annual screening of vitamin B12 level is recommended [65].…”

Section: Adult T2dmentioning

confidence: 99%

New Insight into Metformin Mechanism of Action and Clinical Application

Yan¹,

Kover²,

Moore³

2020

Metformin [Working Title]

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Metformin is the first-line medication for Type 2 diabetes (T2D) treatment, and it is the only US FDA approved oral antidiabetic medication for pediatric patients with T2D 10 years and older. Metformin is also used to treat polycystic ovary syndrome (PCOS), another condition with underlying insulin resistance. The clinical applications of metformin are continuing to expand into other fields including cancer, aging, cardiovascular diseases, and neurodegenerative diseases. Metformin modulates multiple biological pathways. Its novel properties and effects continue to evolve; however, its molecular mechanism of action remains incompletely understood. In this chapter, we focus on the recent translational research and clinical data on the molecular action of metformin and the evidence linking the effects of metformin on insulin resistance, prediabetes, diabetes, aging, cancer, PCOS, cardiovascular diseases, and neurodegenerative diseases. Metformin 2 Mechanisms of actionThe potential mechanisms of metformin action involve several pathways. The AMPK-pathway plays an important role in metformin actions [2, 3]. Metformin inhibits the mitochondrial respiratory chain (complex I), which increases the AMP to ATP ratio, leading to the phosphorylation of AMP-activated protein kinase (AMPK) at Thr-172. We have demonstrated that metformin treatment increases protein level of phosphorylated AMPK in high-glucose-treated endothelial cells [4]. The phosphorylated AMPK subsequently phosphorylates multiple downstream effectors to regulate cellular metabolism and energy homeostasis [5]. These downstream effectors include thioredoxin interacting protein (TXNIP) and TBC1D1, a RAB-GTPase activating protein and a member of the tre-2/BUB2/cdc1 domain family. Phosphorylated TXNIP and TBC1D1 increase the plasma membrane localization of glucose transporter 1 (GLUT1) and GLUT4, respectively [6, 7], and regulate glycogen synthases (GYS1 and GYS2) to prevent the storage of glycogen [8]. Some actions of metformin have been found to be AMPK-independent [9].In diabetic mice, metformin has an effect on gut microbiota by inducing a profound shift in the gut microbial community profile, resulting in an increase in the Akkermansia spp. population [10] and cAMP-induced agmatine production [11], which may decrease absorption of glucose from the gastrointestinal tract and increase lipid metabolism respectively. In addition, metformin decreases insulin-induced suppression of fatty acid oxidation and lowers lipid content of hepatic cells [12].New Insight into Metformin Mechanism of Action and Clinical Application DOI: http://dx.doi.org/10.5772/intechopen.91148 association with insulin resistance. Metformin decreases the level of circulating branched-chain amino acids and reduces insulin resistance in a high-fat diet mouse model [22]. Metformin treatment lowers plasma ADMA which is associated with improved glycemic control in patients with T2D [23].Recent studies indicate that phosphatidylinositol-3-kinase/protein kinase B protein (PI3K/PKB, also known as ...

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Citizen Petition to the US Food and Drug Administration to Change Prescribing Guidelines: The Metformin Experience

Cited by 29 publications

References 4 publications

Differences in National Diabetes Treatment Patterns and Trends between Older and Younger Adults

Differences in National Diabetes Treatment Patterns and Trends between Older and Younger Adults

Metformin: clinical use in type 2 diabetes

New Insight into Metformin Mechanism of Action and Clinical Application

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